BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLENDETONE FACE

    MDR report key: 5403568 · Received February 2, 2016

    Report

    Report Number
    8020867-2015-00016
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    October 15, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BIO-MEDICAL RESEARCH LTD
    Product Code
    NGX
    PMA / PMN Number
    K103031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS TESTED AND NO FAULT WAS FOUND. CONSUMERS ORAL SURGEON COULD DID NOT CONFIRM THE DEVICE AS THE CAUSE OF HER INJURY. (B)(6) MD AND BMRS TECHNICAL DIRECTOR REVIEWED THE EVIDENCE AND CONCLUDED THE DEVICE WAS TESTED AND IS WORKING NORMALLY AND THAT THERE WAS NO CAUSAL LINK BETWEEN THE USE OF THE SLENDERTONE DEVICE AND THE REPORTED EVENT. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR

    Description of Event or Problem · 1

    CONSUMER BOUGHT HER FACE UNIT IN (B)(6) 2011. SHE REPORTED IN (B)(6) 2012 THE INTENSITY OF HER FACE UNIT WAS VERY WEAK AND SHE WAS PROVIDED WITH A REPLACEMENT. SHE LATER REPORTED THE INTENSITY IN THE REPLACEMENT UNIT WAS ALSO WEAK AND REQUESTED A REFUND. WHILE THE RETURNED UNIT WAS BEING TESTED, THE CONSUMER CONTACTED THE CALL CENTRE TO STATE SHE WANTED A REFUND AND NOT A REPLACEMENT. SHE ALSO STATED SHE HAD AN ACHE IN HER JAW AND IT WAS PAINFUL TO EAT. THE CONSUMER WAS REFUNDED. SHE LATER CONTACTED BMR AGAIN TO SAY SHE HAD BEEN UNABLE TO EAT PROPERLY AND HER ORTHOPEDIC SURGEON COULD FIND A REPRODUCIBLE CLICK COMING FROM THE RIGHT TEMPORO-MANDIBULAR JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62511 SLENDETONE FACE POWERED MUSCLE STIMULATOR NGX BIO-MEDICAL RESEARCH LTD 371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other